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The goal of this feasibility clinical trial is to assess the acceptability of ultrasound-guided sciatic nerve block when performed at Emergency Departments for manipulation and temporary stabilization of distal leg and ankle fractures.
The trial aims to assess:
In addition to that, this study aims to
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sciatic Nerve block Arm (Single Arm) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-guided Sciatic Nerve block (20 mL of 2% Lidocaine) | Procedure | Patients will be scanned with the ultrasound machine to determine the technical feasibility of sciatic nerve blocks. If feasible, one of the following techniques will be performed a) popliteal sciatic nerve block, with either lateral or posterior approach; b) CAPS (crosswise approach to popliteal sciatic) block, with either lateral to medial or anterolateral to posteromedial approach; c) subgluteal sciatic nerve block; d) transgluteal sciatic nerve block. In all cases, 20 mL of 2% Lidocaine will be used. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the technical feasibility of ultrasound-guided sciatic nerve block when performed at Emergency Departments for manipulation and temporary stabilization of distal leg and ankle fractures. | Percentage of patients for whom the block is deemed technically feasible by the investigator in charge of this task | From patient recruitment until sciatic nerve scanning (an estimated time frame of 30 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success of US-guided sciatic nerve block | Percentage of patients treated with sciatic nerve block who develop complete or mild- score 0 or 1 - sensory deficit 15 minutes post block | 15 Minutes post US-guided sciatic nerve block |
| Analgesic efficacy of US-guided sciatic nerve block |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint | Number and type of adverse events in the first 48 hours post intervention | In the first 48 hours post intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Santi Di Pietro, MD | Contact | +39 0382 502750 | santi.dipietro@unipv.it |
| Name | Affiliation | Role |
|---|---|---|
| Santi Di Pietro, MD | University of Pavia - IRCCS San Matteo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Department, IRCCS Fondazione Policlinico San Matteo | Pavia | 27100 | Italy |
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| ID | Term |
|---|---|
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Interventional, single-arm, feasibility trial
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|
Percentage of patients manipulated after a successful sciatic nerve block who report Pain Max < 40 mm |
| An estimated average time of 15 minutes after the beginning of fracture manipulation |
| Patient-reported and physician-reported satisfaction | Patient's satisfaction and Treating physician's satisfaction assessed with a 5-points Likert scale. | An estimated average time of 30 minutes after the beginning of fracture manipulation |
| Aniline Compounds |
| D000588 | Amines |